Otc - Active Ingredient
Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)
Swab
FDA Label NDC 68599-8630
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical Inc. for the product Swab (NDC 68599-8630). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Health-care antiseptic for preparation of the skin prior to surgery.
First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.
Warnings
For external use only.
Do not use or apply • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor
Discontinue use if irritation and redness develop
Consult a doctor in case of • deep or puncture wounds • animal bites • serious burns
Stop use and consult a doctor if the condition persists or gets worse
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
For preparation of the skin prior to surgery • clean the affected area • remove swab by stick • apply to the operative site prior to surgery
For use as a first aid antiseptic • clean the affected area • apply a small amount of this product on the area 1 - 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first
Other Safety Information
Store at 59-86°F (15-30°C).
Inactive Ingredient
Citric Acid, Sodium Hydroxide, Nonoxynol-10, Glycerin, Water.
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